For Patients

Ranexa (ranolazine) is a medication that belongs to the drug class known as cardiovascular agents.
Ranexa is prescribed for the treatment of chronic angina. Common side effects of Ranexa include dizziness, nausea, constipation, headache, swelling in hands, ankles, or feet, slow, fast, or irregular heartbeats, tremors, blood in the urine and shortness of breath.

Ranexa dose range is 500 mg to 1000 mg twice daily. Ranexa drug interactions include, Biaxin (clarithromycin), Kaletra (ritonavir), Diflucan (fluconazole), Sandimmune (cyclosporine), Rifadin (rifampin), Dilantin (phenytoin), Tegretol (carbamazepine) and Zocor (simvastatin). There are no adequate studies of Ranexa in pregnant women and it should only be used during pregnancy if the potential benefit outweighs the potential risk to the fetus. It is not known if Ranexa is excreted in human milk.

Our Ranexa Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in practice.

A total of 2,018 patients with chronic angina were
treated with ranolazine in controlled clinical trials. Of the patients treated
with RANEXA, 1,026 were enrolled in three double-blind, placebocontrolled, randomized
studies (CARISA, ERICA, MARISA) of up to 12 weeks' duration. In addition, upon
study completion, 1,251 patients received treatment with RANEXA in open-label, long-term
studies; 1,227 patients were exposed to RANEXA for more than 1 year, 613
patients for more than 2 years, 531 patients for more than 3 years, and 326
patients for more than 4 years.

At recommended doses, about 6% of patients discontinued
treatment with RANEXA because of an adverse event in controlled studies in
angina patients compared to about 3% on placebo. The most common adverse events
that led to discontinuation more frequently on RANEXA than placebo were
dizziness (1.3% versus 0.1%), nausea (1% versus 0%), asthenia, constipation,
and headache (each about 0.5% versus 0%). Doses above 1000 mg twice daily are
poorly tolerated.

In controlled clinical trials of angina patients, the
most frequently reported treatment-emergent adverse reactions ( > 4% and more
common on RANEXA than on placebo) were dizziness (6.2%), headache (5.5%),
constipation (4.5%), and nausea (4.4%). Dizziness may be doserelated. In
open-label, long-term treatment studies, a similar adverse reaction profile was
observed.

The following additional adverse reactions occurred at an
incidence of 0.5 to 4.0% in patients treated with RANEXA and were more frequent
than the incidence observed in placebo-treated patients:

A large clinical trial in acute coronary syndrome
patients was unsuccessful in demonstrating a benefit for RANEXA, but there was
no apparent proarrhythmic effect in these high-risk patients [seeClinical
Studies].

Laboratory Abnormalities

RANEXA produces elevations of serum creatinine by 0.1
mg/dL, regardless of previous renal function. The elevation has a rapid onset,
shows no signs of progression during long-term therapy, is reversible after
discontinuation of RANEXA, and is not accompanied by changes in BUN. In healthy
volunteers, RANEXA 1000 mg twice daily had no effect upon the glomerular filtration
rate. The elevated creatinine levels are likely due to a blockage of
creatinine's tubular secretion by ranolazine or one of its metabolites.

Postmarketing Experience

The following adverse reactions have been identified
during postapproval use of RANEXA. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always possible to
reliably estimate their frequency or establish a causal relationship to drug exposure:

Nervous System Disorders

Tremor, paresthesia, abnormal coordination, and other
serious neurologic adverse events have been reported to occur, sometimes
concurrently, in patients taking ranolazine. The onset of events was often
associated with an increase in ranolazine dose or exposure. Many patients reported
symptom resolution following drug discontinuation or dose decrease.